System and method for minimally invasive ultrasonic musculoskeletal tissue treatment

ABSTRACT

Delivering ultrasonic energy to a target musculoskeletal tissue site includes connecting a delivery device to a vacuum source, a fluid source, and a power signal source. The delivery device has a housing portion maintaining an ultrasound transducer and a tip portion having a sleeve and a cannula. The cannula is coupled to the ultrasound transducer and received in the sleeve to define a covered portion and an exposed portion. Ultrasonic energy is generated by sending a power signal from the power signal source to the ultrasound transducer. The ultrasonic energy is transmitted from the ultrasound transducer to the cannula, such that the exposed portion of the cannula delivers ultrasonic energy at a frequency that is pre-selected to debride musculoskeletal tissue upon percutaneous insertion of the tip portion.

BACKGROUND

Repetitive motion or use of particular body tissues can cause injuriesor painful conditions to arise. For example, tennis elbow, or lateralepicondylalgia is a clinical syndrome in which patients experience painat the lateral elbow. Such pain in the lateral elbow may be worsen overtime and, despite adequate treatment, many patients develop chronicsymptoms and eventually become candidates for surgical treatment.

A number of surgical procedures have been described to treat chroniclateral epicondylalgia. Particular open techniques typically requireopen surgical dissection down to the pathological tissue and thereforenecessitate repair of the surgically compromised normal tissue. Somearthroscopic techniques can be slightly less invasive, but thesearthroscopic elbow techniques have been associated with neurologicalcomplications and may require the use of a high-cost operating suite andassociated personnel. Various percutaneous techniques have beendescribed which release, ablate or resect the pathological tissue. Thesepercutaneous techniques, however, generally require a noticeable skinincision, some surgical dissection, and the afore-mentioned use of ahigh-cost operating suite and supportive equipment and personnel.

SUMMARY

Some embodiments relate to a system for musculoskeletal tissue treatmentunder ultrasonic guidance. The system includes a delivery device and acontroller adapted to deliver a power signal to the delivery device. Thedelivery device is adapted to deliver ultrasonic energy tomusculoskeletal tissue and includes a housing portion, an ultrasoundtransducer, and a tip portion. The housing portion defines a compartmentand has an aspiration conduit and an irrigation conduit. The ultrasoundtransducer is disposed in the compartment of the housing portion and isadapted to translate a power signal to ultrasonic energy. The tipportion is coupled to the housing portion and is adapted to deliverfluid coming through the irrigation conduit to a musculoskeletal tissuesite and to deliver detritus coming from the musculoskeletal tissue sitethrough the aspiration channel. The tip portion includes a cannula and asleeve. The cannula has a proximal portion and a distal portion, wherethe cannula is coupled to the ultrasound transducer to receiveultrasonic energy from the ultrasound transducer and deliver theultrasonic energy to the musculoskeletal tissue site. The sleeve isadapted for percutaneous insertion and forms a lumen receiving theproximal portion of the cannula.

Some embodiments relate to delivering ultrasonic energy to a targetmusculoskeletal tissue site. A delivery device is connected to a vacuumsource, a fluid source, and a power signal source. The delivery devicehas a housing portion maintaining an ultrasound transducer and a tipportion having a sleeve and a cannula. The cannula is coupled to theultrasound transducer and received in the sleeve to define a coveredportion and an exposed portion. Ultrasonic energy is generated bysending a power signal from the power signal source to the ultrasoundtransducer. The ultrasonic energy is transmitted from the ultrasoundtransducer to the cannula, such that the exposed portion of the cannuladelivers ultrasonic energy at a frequency that is pre-selected todebride musculoskeletal tissue upon percutaneous insertion of the tipportion.

While multiple embodiments are disclosed, still other embodiments willbecome apparent to those skilled in the art from the following detaileddescription, which shows and describes various examples forunderstanding. Accordingly, the drawings and detailed description are tobe regarded as illustrative in nature and not restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a system for accessing and treating tissue, according tosome embodiments.

FIG. 2 is a longitudinal section of a delivery device of the system ofFIG. 1, according to some embodiments.

FIG. 3 is an enlarged perspective view of a tip portion of the deliverydevice of FIG. 1, according to some embodiments.

FIG. 4 is a longitudinal section of the view of FIG. 3, according tosome embodiments.

FIG. 5 is a schematic view of a controller of the system of FIG. 1,according to some embodiments.

FIG. 6 is a schematic view of a user interface of the controller of FIG.5, according to some embodiments.

FIGS. 7A, 7B, and 7C show a tubing cassette of the controller of FIG. 5,according to some embodiments.

FIG. 8 shows a tenotomy procedure using the system of FIG. 1 underultrasonic guidance, according to some embodiments.

While the inventive aspects are amenable to various modifications andalternative forms, embodiments have been shown by way of example in thedrawings and are described in detail below. The intention, however, isnot to limit the inventive aspects to the particular embodiments shownand described. On the contrary, the invention is intended to cover allmodifications, equivalents, and alternatives falling within the scope ofinvention as defined by the appended claims.

DETAILED DESCRIPTION

Various embodiments described herein provide systems for accessing andtreating target body tissue (e.g., tendon tissue, ligament tissue,muscle tissue, bony tissue, and the like) under guidance of ultrasoundimaging equipment. In some embodiments, the system includes a deliverydevice that is pre-tuned to an ultrasonic energy frequency rangeselected for debridement of pathologic musculoskeletal tissue. Accordingto some embodiments, the delivery device, also termed a hand piece,includes echogenic material and/or etching to facilitate ultrasonicimaging and is adapted for percutaneous insertion without producing anoticeable skin incision. Portions of the system, including the deliverydevice and associated tubing set, are optionally adapted to be discardedafter a single use.

In some implementations, a high-frequency ultrasound transducer andassociated ultrasound imaging equipment provide visual detail of thetendinopathic changes of lateral epicondylalgia, so pathologic tissue isbetter identified at the time of a procedure without the need to cut theskin. Thereafter, pathologic tissue or other target tissue is accessibleand treatable using the system without a noticeable skin incision. Oneprocedure includes an ultrasound-guided percutaneous tenotomy forchronic lateral epicondylalgia, where the use of ultrasound equipmentand echogenic instrumentation helps provide precise localization andtreatment of the pathological tissue under real-time guidance whileminimizing trauma to non-affected tissues. Other tissues in the elbowjoint and in other parts of the body are contemplated for treatmentusing systems described herein. Also, in some embodiments, systemsadditionally or alternatively serve to deliver therapeutic agents to thesite before or after tissue is treated or are used to accomplish avariety of tissue treatments (e.g., tissue disruption, debridement,decortication, or others).

FIG. 1 shows a system 10 for percutaneously accessing and acting upontarget tissue while helping reduce collateral trauma, according to someembodiments. In some embodiments, the percutaneous, minimally-invasivenature of the system 10 facilitates treatment of a patient in an officesetting under local anesthesia. Treatment in an office setting isadvantageous in several respects, including patient comfort andconvenience and avoiding costs associated with operating room time andgeneral anesthesia, for example. The system 10 includes a deliverydevice 12 adapted to deliver ultrasonic energy to musculoskeletal tissueand a controller 14 connected to the delivery device 12 (e.g., via wiredcommunication, wireless communication, or combinations thereof).Generally, various components of the delivery device 12 contemplated fortissue contact are formed of biocompatible and/or other suitablematerials depending upon implementation.

As shown in FIG. 1, the delivery device 12, also described as a handpiece, is optionally ergonomically designed, adapted to be hand held(e.g., as a stylet) or otherwise adapted to be manually operated using asingle hand. In other implementations, the delivery device 12 is adaptedto be manipulated automatically or semi-automatically (e.g., as part ofa robotic system). FIG. 2 shows a longitudinal section of the deliverydevice 12, according to some embodiments. As shown in FIG. 2, thedelivery device 12 includes a housing portion 20, an ultrasoundtransducer 22 maintained within the housing portion 20, and a tipportion 24 that is removably coupled to the housing portion 20,according to some embodiments.

In some embodiments, the housing portion 20 provides means formaintaining the transducer 22 and forms an irrigation conduit 26 and avacuum conduit 28, where the housing portion 20 includes a body 30 and amounting post 32 received in the body 30. As illustrated, portions ofthe irrigation and vacuum conduits 26, 28 are formed by the body 30 andmounting post 32. The body 30 defines an inner compartment 34 andextends from a proximal end 36 to a distal end 38, the body 30 forming anose portion 40 toward the distal end 38, a grip portion 42 proximalfrom the nose portion 40, and a fluid bypass 44 separated from andextending adjacent to the inner compartment 34. In some embodiments, thebody 30 is formed of Acrylonitrile Butadiene Styrene, although a varietyof materials are contemplated.

As shown, the inner compartment 34 is generally an elongate space withinthe body 30, extending through the grip portion 42 distally through thenose portion 40. In some embodiments, the inner compartment 34 isadapted to receive the ultrasound transducer 22 and the mounting post32, as well as any other incorporated components (e.g., a power signalsource such as a battery and control circuitry, or other features) andforms a part of the irrigation conduit 26 in combination with themounting post 32 as subsequently described.

In some embodiments, the nose portion 40 is generally narrowed indiameter relative to the grip portion 42. As shown, the nose portion 40optionally includes external threading 50 for releasably mating with thetip portion 24.

In some embodiments, the grip portion 42 includes a contoured profile toenhance grip and facilitate manual control of the device 12 by a user.As shown, the fluid bypass 44 extends along an external portion of thegrip portion 42 according to some implementations, where the fluidbypass 44 defines a hollow lumen 54 having an inlet 56 from the innercompartment 34 near the proximal end 36 of the body 30 and an outlet 58back into the inner compartment 34. As subsequently described, the fluidbypass 44 also forms a portion of the irrigation conduit 26.

In some embodiments, the mounting post 32 includes a neck 64, a collar66, and a stem 68 and defines an inner lumen 70 which forms a portion ofthe vacuum conduit 28. The neck 64 is elongate and tubular and includesinternal threading 72 within the inner lumen 70. The collar 66 has arelatively larger diameter than the neck 64 and resides intermediate theneck 64 and stem 68, where the neck 64 extends distally from the collar66 and the stem 68 extends proximally from the collar 66. As shown, thecollar 66 optionally includes a gasket 74, or O-ring, for forming afluid seal with the inner compartment 34 of the body 30 proximal to theoutlet 58 of the fluid bypass 44. The stem 68 has a relatively smallerdiameter than the collar 66 and is adapted to coaxially receive theultrasound transducer 22 according to some embodiments. In order tofacilitate assembly, the stem 68 is optionally formed of first andsecond tubular members 68A, 68B coupled via complementary threadingand/or a frictional fit, for example.

In some embodiments, the neck 64, the collar 66, and the first tubularmember 68A of the stem 68 are formed of a material that is suitable forconveying ultrasonic energy. For example the neck 64, collar 66, and thefirst tubular member 68A are optionally formed of a stainless steelalloy, although a variety of materials are contemplated. In someembodiments, the second tubular member 68B of the stem 68A is formed ofa dampening or insulating material, such as a relatively soft polymericmaterial, for reducing or inhibiting proximal transmission of ultrasonicenergy or other undesirable ultrasonic energy transmission. For examplethe second tubular member 68B is optionally formed ofpolytetrafluoroethylene, although a variety of materials arecontemplated.

The ultrasound transducer 22, or transducer 22, is maintained in theinner compartment 34 of the housing portion 20 by the mounting post 32and provides means for generating ultrasonic energy from a power signal.The ultrasonic energy is optionally applied in a pulsed fashion orcontinuous fashion as desired. The transducer 22 optionally takes avariety of forms, but according to some embodiments includes anenclosure 80 housing a plurality of piezoelectric crystals 82 andelectrodes and a power conduit 84 for carrying a power signal to thetransducer 22. In particular, the transducer 22 is adapted to translatea power signal from the controller 14 to ultrasonic energy. Theenclosure 80 of the transducer 22 is mounted to first tubular member 68Aof the stem 68 such that ultrasonic energy generated by the transducer22 is conveyed into and through the mounting post 32 distally to theneck 64 of the mounting post 32. The transducer 22 is optionally adaptedto generate longitudinal vibration, transverse vibration, orcombinations thereof at desired frequencies. For example, the number andconfiguration of the piezoelectric crystals 82 are optionally varied tomodify the ultrasonic frequency used for tissue treatment.

With the transducer 22 secured coaxially about the mounting post 32, theinner lumen 70, and thus the vacuum conduit 28, pass through thetransducer 22. As shown in FIG. 2, the vacuum conduit 28 is generallyformed by the mounting post 32, where the inner lumen 70 of the mountingpost 32 provides an aspiration duct through the housing portion 20. Tofacilitate assembly of the system 10, the second tubular member 68B isoptionally secured to the proximal end 36 of the body 30 and capped witha connector as desired. In some embodiments, the second tubular member68B is configured to include a removable filter and/or a collectioncontainer for collecting and filtering detritus from the target site.

As shown, the irrigation conduit 26 is formed by a combination of thebody 30 and mounting post 32 of the housing portion 20. In someembodiments, assembly of the housing portion 20 and the mounting post 32includes coaxially receiving the mounting post 32 within the innercompartment 34 of the body 30 such that the gasket 74 engages the body30 proximal to the outlet 58 of the fluid bypass 44. The mounting post32 is optionally frictionally fit, adhered, welded, or otherwise securedwithin the body 30 according to various embodiments. The power conduit84 of the transducer 22 is extended distally from the enclosure 80,secured to the proximal end 36 of the body 30, and is optionally cappedwith a connector as desired.

The irrigation conduit 26 is defined by a first portion 26A, a secondportion 26B, a third portion 26C, and a fourth portion 26D. The firstportion 26A optionally includes a tubular connector secured to the body30 at the proximal end 36 and coupled to the inlet 56 of the fluidbypass 44. The second portion 26B includes the fluid bypass 44. Thethird portion 26C includes a portion of the inner compartment 34 betweenthe neck 64 of the mounting post 32 and the body 30 that is distal tothe collar 66 of the mounting post 32 and proximal to the nose portion40 of the body 30. The fourth portion 26D includes a part of the innercompartment 34 between the nose portion 40 of the body 30 and the neck64 of the mounting post 32. Thus, fluid flow F passing into theirrigation conduit 28 in a distal direction passes sequentially throughthe first, second, third, and fourth portions 26A, 26B, 26C, 26D withfluid encircling, or circumscribing the neck 64 of the mounting post 32.

In some embodiments, the tip portion 24 is adapted to be coupled to thehousing portion 20, deliver fluid coming through the irrigation conduit26 to a target site, deliver detritus flow D coming from the target siteinto the vacuum conduit 28, and deliver ultrasonic energy from thetransducer 22 (conveyed via the mounting post 32) to the target site. Assubsequently described in greater detail, in some embodiments, the tipportion 24 provides means for transmitting the ultrasonic energy to apercutaneous musculoskeletal site at a pre-tuned frequency selected todebride musculoskeletal tissue.

FIG. 3 is an enlarged isometric view of the tip portion 24 with the bodyportion 22 of the device 12 being largely cut away and FIG. 4 is alongitudinal section of the view of FIG. 3, according to someembodiments. As shown in FIG. 3, the tip portion 24 defines a distalsection 24A adapted for percutaneous insertion without having to form anincision in the skin and a proximal section 24B adapted for coupling tothe housing portion 20.

As shown in FIG. 4, the tip portion 24 includes a cannula 90 and asleeve 92 covering a section of the cannula 90 to define a coveredportion 90A and an exposed portion 90B of the cannula 90. The tipportion 24 also defines an irrigation conduit 96 and a vacuum conduit98. In some embodiments the cannula 90 is a generally hollow tubularmember having a distal, insertion portion 100 and a proximal, couplingportion 102. The cannula 90 also defines an inner lumen 104 extendinglongitudinally through the insertion and coupling portions 100, 102. Insome embodiments, the cannula 90 is formed of an echogenic,biocompatible material suitable for conveying ultrasonic energy. Forexample, the cannula 90 is optionally formed of a stainless steel alloyaccording to various embodiments. In other embodiments, the cannula 90is covered or coated with echogenic material.

In some embodiments, the coupling portion 102 of the cannula 90 includesa threaded base 108 and a flange 110 extending distally from thethreaded base 108. The threaded base 108 is adapted to mate with theinternal threading 72 of the mounting post 32 with the flange 110abutting the mounting post 32. The flange 110 has a relatively largerdiameter than the threaded base 108 and necks down in diameter totransition to the insertion portion 100. The insertion portion 100 ofthe cannula 90 extends smoothly from the coupling portion 102 of thecannula 90 to a terminal end 114 and is adapted for percutaneousinsertion.

In some embodiments, the terminal end 114 of the insertion portion 100is formed at a sharp angle or in other embodiments is simply squared off(not shown). Additionally, the insertion portion 100 optionally includesserrated edges or other surface features (not shown) for enhancingultrasonic debridement.

In some embodiments, the insertion portion 100 of the cannula 90 has asize of about 12 gauge or less, about 12 gauge to about 25 gauge, orabout 14 gauge to about 22 gauge, for example. In some embodiments, theinsertion portion 100 has a lateral width of about 2.5 mm or less, about2.2 mm to about 0.4 mm, or about 2.1 mm to about 0.5 mm, for example. Insome embodiments, the length of the insertion portion 100 is about 3.0inches to about 0.25 inches, about 2.7 inches to about 0.5 inches, orabout 2.5 inches to about 1.0 inch, for example. Although some examplesare provided herein which facilitate percutaneous insertion, otherdimensions are also contemplated.

As shown in FIG. 4, the sleeve 92 is a generally hollow tubular memberadapted to extend over the covered portion 90B of the cannula 90. Insome embodiments, the sleeve 92 reduces unwanted, collateraltransmission of heat, ultrasonic energy, or other byproducts of theultrasonic energy being conveyed along the covered portion 90B of thecannula 90 and also helps provide a path for irrigation fluid to theexposed portion 90A of the cannula 90. According to some embodiments,the sleeve 92 reduces or eliminates damage to non-target body tissues asa result of unwanted transmission of ultrasonic energy.

Similarly to the cannula 90, the sleeve 92 has a proximal, couplingportion 116 and a distal, insertion portion 118 extending from thecoupling portion 116 and defining an inner lumen 120. The sleeve 92 or aportion thereof is optionally formed of an echogenic, biocompatiblematerial suitable for dampening products of ultrasonic energy (e.g.,heat and vibration). In other embodiments, the sleeve 92 is coated withan echogenic material. In some implementations, the sleeve 92 is formedof a material exhibiting a differential echogenicity to that of thecannula 90. In such embodiments, both the cannula 90 and sleeve 92facilitate ultrasonic imaging and separate identification duringpercutaneous insertion. For example, in some embodiments the sleeve 92is formed of an echogenic polytetrafluoroethylene, although othermaterials are contemplated.

As shown, the coupling portion 116 of the sleeve 92 includes internalthreading 126 adapted to mate with nose portion 40 of the body 30 andnecks down in diameter to transition to the insertion portion 118 of thesleeve 92. The coupling portion 116 also includes a gasket 128 or O-ringfor forming a fluid seal with the nose portion 40. The insertion portion118 of the sleeve 92 extends smoothly from the coupling portion 116 to aterminal end 130 and is adapted for percutaneous insertion.

The terminal end 130 of the insertion portion 118 is optionally formedwith a sharp angle or in other embodiments is simply squared off (notshown). In some embodiments, the insertion portion 118 is adapted toleave the exposed portion 90B of the cannula 90 a length of about 10 mmor less, for example between from 2 mm to about 10 mm, although avariety of dimensions are contemplated.

In some embodiments, and depending upon the size of the cannula 90 asthe sleeve 92 receives the cannula 90, the insertion portion 118 of thesleeve 92 has a size of about 12 gauge or less, about 12 gauge to about25 gauge, or about 14 gauge to about 22 gauge, for example. In someembodiments, the insertion portion 118 has a lateral width of about 2.5mm or less, about 2.2 mm to about 0.4 mm, or about 2.1 mm to about 0.5mm, for example. In some embodiments, the length of the insertionportion 118 is about 3.0 inches to about 0.25 inches, about 2.7 inchesto about 0.5 inches, or about 2.5 inches to about 1.0 inch, for example.Although some examples are provided herein which facilitate percutaneousinsertion, other dimensions are also contemplated.

As shown in FIG. 4, the vacuum conduit 98 is generally formed by thecannula 90, where the inner lumen 104 of the cannula 90 provides anaspiration duct through the tip portion 24 with an inlet at the terminalend 114 of the cannula 90. In turn, the irrigation conduit 96 is formedupon securing the cannula 90 and the sleeve 92 relative to one another.In some embodiments, the cannula 90 and sleeve 92 are separately securedto the housing portion 20 of the delivery device 12 and do not contactone another. Once the cannula 90 and the sleeve 92 are secured relativeto one another, with the cannula received in the inner lumen 120 of thesleeve 92, the cannula 90 and the sleeve 92 define a gap between them toform the irrigation conduit 96 of the tip portion 24, with an inlet 96Ainto the irrigation conduit 96 being defined between the couplingportions 100, 116 of the cannula 90 and the sleeve 92, the inlet 96Abeing positioned distal to the gasket 128. An outlet from the irrigationconduit 96B is defined between the terminal end 130 of the sleeve 92 andthe cannula 90. Thus, fluid F passing into the irrigation conduit 96 ina distal direction passes from the irrigation conduit 26 into the inlet96A and out from the outlet 96B with fluid generally encircling, orcircumscribing the insertion portion 100 of the cannula 90 and beingdirected toward the exposed portion 90B of the cannula 90.

In some embodiments, assembly of the delivery device 12 includesremovably securing the tip portion 24 to the housing portion by screwingthe tip portion 24 onto the housing portion 20 with the coupling portion102 of the cannula 90 coming into close contact with the neck 64 of themounting post 32 such that ultrasonic energy generated by the transducer22 is transferred from the mounting post 32 to the cannula 90 and vacuumis able to be pulled through the vacuum conduits 28, 98. Also, thegasket 74 of the tip portion 24 seals sleeve 92 to the nose portion 40such that fluid is able to be delivered through the irrigation conduits26, 96.

As previously referenced, in some embodiments, the insertion portions100, 118 of the tip portion 24 help facilitate atraumatic skin and softtissue penetration—also described as percutaneous access without a needfor a separate incision—under ultrasonic imaging. Moreover, in someembodiments, the delivery device 12 is pre-tuned to a selectedultrasonic energy frequency or frequency range. For example, it hassurprisingly been found that an ultrasonic energy frequency range fromabout 25 kHz to about 29 kHz effectively debrides pathologicmusculoskeletal tissue (e.g., scar tissue associated with a tendon)while reducing the likelihood of trauma to healthy soft tissue. Variousfeatures of the delivery device 12 influence the ultrasonic energyfrequency being delivered from the exposed portion 90B of the cannula90, including size, shape, and material of the mounting post 32, size,shape, and material of the cannula 90, and configuration of thetransducer 22 (including size, shape, and number of piezoelectriccrystals, for example).

FIG. 5 is a schematic view of the controller 14, according to someembodiments. As shown, the controller 14 includes a housing 200; acommand module 202 including a user interface 204, a power source 206,and a processor 207; a vacuum source 208; an irrigation source 210; anda tubing cassette 212.

The housing 200 is generally shown in FIG. 1 and serves to house thevarious components and provide connector ports, for example. The commandmodule 202 is adapted to control flow from the vacuum source 208,control flow from the irrigation source 210, power the delivery device12, and send and receive instructions to and from a user via the userinterface 204, where the processor 207 of the command module 202includes software and hardware (e.g., ASIC or general purposes ICs,memory, ports, etc.) for providing means to generate and deliver a powersignal to the delivery device 12. In some embodiments, the commandmodule 202 includes signal filter means 207A for delivering aconditioned power signal (e.g., a sinusoidal power signal at a selectedamplitude and frequency) to the delivery device 12.

In some embodiments, the user interface 204 includes a touch screensystem and provides a means for controlling the system 10 via asequentially-oriented operation process as will be subsequentlydescribed. The power source 206 optionally includes a battery, acapacitor, a transformer connected to an external power source, such asa wall socket, combinations thereof, or other means for providingelectrical power to the system 10. As generally illustrated, in someembodiments, the power source 206 directly or indirectly delivers powerto the various components of the controller 14 as appropriate.

As shown, the vacuum source 208 is optionally a vacuum pump (e.g., aperistaltic pump) disposed within the housing 200, though in otherembodiments the vacuum source 208 is a connection to an external vacuumsource (e.g, “house” vacuum), or other source for providing vacuum oraspiration flow D. The controller 14 also optionally includes acollection container 208A for receiving detritus, fluid, or other matterbeing aspirated by the aspiration flow D. The irrigation source 210includes a reservoir of irrigant (e.g., saline) that is pressurized bygravity, a plunger (e.g., a syringe), or a pump (e.g., a peristalticpump operated by the controller 14 and optionally disposed within thehousing 200) to generate fluid flow F. The controller 14 also optionallyincludes a valve actuator 214 for directing fluid flow F into the vacuumconduits 28, 98 of the delivery device 12, for example to for flushingpurposes.

FIG. 6 shows a display of the user interface 204. In operation, the userinterface 204 provides a user (not shown) an intuitive sequence foroperating the system 10 as will be described in greater detail below. Asshown, the user interface 204 includes a prime phase 220, a purge phase222, and a reset phase 224 and allows sequential operation of thedelivery device 12 starting with an ultrasound level selection 230, anirrigation level selection 232, and an aspiration level selection 234,where a user is allowed to first select the ultrasound level 230, thenthe irrigation level 232, and finally the aspiration level 234 insequence when operating the system 10. In some embodiments, theselections 230, 232, 234 are illuminated sequentially, first with theultrasound level selection 230, and a user is not allowed to make asubsequent selection until the selection at hand has been made. In somemethods of operation, the ultrasound energy and irrigant, or fluid flow,are generally delivered concurrently, while aspiration flow is deliveredintermittently. For example, the ultrasound energy and irrigant flowoptionally cease during aspiration and are restarted once treatment isreinitiated. Alternatively, irrigant flow ceases and ultrasound energycontinues during aspiration, although some of the beneficial effectsfrom using irrigant during ultrasonic treatment (e.g., continuous tipcooling and tissue emulsification, as well as others) are potentiallyreduced by such operation.

As indicated by the block arrow in FIG. 5, the tubing cassette 212 isremovable from the housing 200 and includes a housing 296, a valve 298,a vacuum line 300, and an irrigation line 302 (designated by brokenlines) maintained by the housing 296, the vacuum and irrigation lines300, 302 providing connections between the vacuum source 208 and thedelivery device 12 and between the irrigation source 210 and thedelivery device 12. The vacuum line 300 is also optionally connected tothe collection container 208A as previously referenced. In someembodiments, the vacuum and irrigation lines 300, 302 include aplurality of interconnected segments of medical tubing, although unitaryconstructs are a potential option as well. Although the collectioncontainer 208A is shown generally separate from the cassette 212, insome embodiments the collection container 208A is maintained by, formedas a part of, or is a component within the cassette 212. In someembodiments, the cassette 212 provides means for connecting the vacuumline 300 to the vacuum source 208 in a relatively sterile manner. Forexample, where the vacuum source 208 includes a peristaltic pump, thecassette 212 includes a seat structure 296A for causing the vacuum line300 to engage a pump drive 208B of the vacuum source 208 that generatesaspiration flow in the vacuum line 300.

FIG. 7A shows an interior side of the tubing cassette 212 and FIG. 7Bshows a bottom side of the tubing cassette 212, according to someembodiments. FIG. 7C is a schematic view of the tubing cassette 212,according to some embodiments. As previously described, the tubingcassette 212 includes a housing 296, a seat structure 296A, a valve 298,a vacuum line 300, and an irrigation line 302 (the vacuum and irrigationlines 300, 302 optionally being collectively referred to as a tubingset). In operation, the pump drive 208B (FIG. 5) of the vacuum source208 (e.g., a peristaltic pump) is received in the seat structure 296Asuch that the vacuum line 300 is engaged against the seat structure 296Abetween the pump drive 208B and the seat structure 296A. The valve 298is engaged by the valve actuator 214 to press the valve 298 closed suchthat flow from the irrigation line 302 will not travel through thevacuum line 300 to the delivery device 12 (designated generally by abroken line rectangle in FIG. 7C). When the vacuum line 300 is to beflushed, for example, the valve 298 is released and fluid is able toflow into the vacuum line 300 to the device and through the vacuumconduits 28, 98. As previously referenced, the irrigant flowing throughthe irrigation line 302 is optionally gravity pressurized or otherwiseforced through the system 10.

Examples of additional or alternative system features andimplementations, including alternate drive mechanism, working tip, andcontroller features as well as various treatment procedures are providedin PCT International Application No. PCT/US2009/034659, published onAug. 27, 2009, having an international filing date of Feb. 20, 2009, andentitled “Systems, Devices and Methods for Accessing Body Tissue,” thecontents of which are incorporated herein by reference in theirentirety. For example, in some embodiments, the housing portion 20 ofthe delivery device 12 includes or is connectable to one or morecomplementary working instruments (not shown), such as a trocar orpercutaneous imaging head.

Assembly of the system 10 includes remotely connecting the deliverydevice 12 to the controller 14, where the controller 14 is a separate,remote module from the delivery device 12. In other embodiments, thedelivery device 12 and the controller 14, or portions thereof, areformed as a single unit.

As indicated in FIGS. 1 and 5, a power line 304 is used to remotelyconnect the controller 14 to the power conduit 84 (FIG. 2) of thetransducer 22 such that the controller 14 is able to supply a powersignal to the delivery device 14. The tubing cassette 212 is removablycoupled to the housing 200 of the controller 14 and the vacuum line 300is connected to the vacuum conduit 28 (FIG. 2) and the irrigation line302 is connected to the irrigation source 210 (FIG. 2). A user (notshown) is then manipulates the delivery device 12 under ultrasonicguidance and control delivery of ultrasonic energy, fluid flow, andvacuum flow using the interface 204 of the controller 14, according tosome embodiment.

FIG. 8 illustrates a method of delivering ultrasonic energy to a targetmusculoskeletal tissue site under ultrasonic imaging. As previouslyreferenced, in some embodiments, the distal section 24A (FIG. 2) of thetip portion 24 is adapted to penetrate the skin and soft tissue, therebyfacilitating percutaneous access to target musculoskeletal tissue site.

As shown in FIG. 8, advancement of the distal section 24A of the tipportion 24 to a target musculoskeletal tissue site 400 is optionallyperformed under guidance of an ultrasound imaging system 402 including ahigh-frequency ultrasound transducer 404 (e.g., a frequency greater thanabout 10 MHz) and an imaging device 406. The imaging system 402, incombination with the echogenic nature of the tip portion 24, permitsintra-operative identification of the target tissue site 400 in need oftreatment and an ability to percutaneously deliver ultrasonic energyfrom the exposed portion 90A of the cannula 90 to the target tissue site400.

Some methods of delivering ultrasonic energy to the target tissue site400 include connecting the delivery device 12 to the vacuum source 208,the irrigation source 210, and the power source 206 of the controller 14(directly or via the command module 202). Ultrasonic energy is generatedby sending a power signal from the command module 202 to the ultrasoundtransducer 22. The ultrasonic energy is transmitted from the ultrasoundtransducer 22 to the cannula 90, such that the exposed portion 90B ofthe cannula 90 delivers ultrasonic energy at a frequency that ispre-selected to debride musculoskeletal tissue upon percutaneousinsertion of the distal section 24A of the tip portion 24 to the targetmusculoskeletal tissue site 400.

As referenced, the user interface 204 is optionally operated by a userto sequentially start up the delivery device 12, including initiatingultrasonic energy delivery, irrigation flow to the device 12, andaspiration flow from the device 12. Once tissue treatment is completed,according some embodiments, the tubing cassette 212 is removed from thecontroller 14, discarded, and replaced with a second, sterile tubingcassette (not shown) and is either pre-connected or subsequentlyconnected to a second, sterile delivery device (not shown) to sterilizethe system 10 for a new procedure.

In some embodiments, a plurality of disposable delivery devices similarto the delivery device 12 are provided with corresponding disposablecassettes, such as the cassette 212 for each delivery device.Individually pre-tuning the devices to an appropriate ultrasonic energyfrequency, such as that previously described, before delivery to theuser removes a need to test and adjust power signal parameters ordelivery device configurations prior to or during each procedure.Instead, in some implementations, a single use cassette/delivery devicekit is set up or configured prior to delivery to the end user, is thenused in a treatment procedure, and is optionally discarded at the end ofthe procedure, thereby reducing operation time, a requisite skill levelfor “tuning” the system 10, and/or additional components or systems fortuning the delivery device 12. Moreover, the combination of the cassette212 and delivery device 12 eliminates a need to sterilize equipmentbefore a procedure, as all components that come into contact with bodilyfluids are pre-sterilized and discarded at the end of the procedure.

According to various embodiments, the system 10 is used in any of avariety of procedures. In some embodiments, the system 10 is used toperform an ultrasound-guided percutaneous tenotomy. Some methods includethe target tissue site 400 being pathologic tissues (e.g., a region ofscar tissue associated with a tendon 410), where the pathologic tissueis identified using high frequency ultrasonic imaging, the tip portion24 is percutaneously delivered, and in particular the distal section24A, to the target tissue site 400 under ultrasonic imaging, andultrasonic energy is delivered through the cannula 90 to debride themusculoskeletal tissue (e.g., scar tissue) forming the target tissuesite 400. Some methods include identifying the target tissue site 400entirely at the time of a procedure without cutting the skin of thepatient. As previously described, in some embodiments the deliverydevice 12 is pre-tuned to deliver ultrasonic energy at a frequency thatreduces the likelihood of trauma to healthy soft tissue while promotingdebridement of the pathologic tissue. Moreover, the percutaneous,minimally invasive nature of such a procedure facilitates access andtreatment of such body tissue as part of an office-based procedure underlocal anesthesia.

According to some methods, after the target tissue is treated and thedistal section 24A of the tip portion 24 is removed from the patient,the patient is discharged to home after a short period of in-officeobservation due to the minimally invasive nature of the procedure (e.g.,as no local anesthesia would be necessary). For example, in similarlynon-invasive procedures, post-procedure pain is typically variable, butoften ranges from essentially no pain to moderately severe pain lastingless than 72 hours. Thus, various embodiments of the system 10 providefor an office-based procedure under local anesthesia, thereby resultingin cost-savings to the patient by avoiding the costs of operating roomtime, where a patient may only need ice or cooling packs for analgesiaand edema control after the treatment.

Although the present invention has been described with reference tovarious examples, persons skilled in the art will recognize that changesmay be made in form and detail without departing from the spirit andscope of invention. For example, various modifications and additions canbe made to the exemplary embodiments discussed without departing fromthe scope of invention. While the embodiments described above refer toparticular features, the scope of invention also includes embodimentshaving different combinations of features and embodiments that do notinclude all of the above described features.

What is claimed is:
 1. A method of delivering ultrasonic energy, themethod comprising: connecting a delivery device to a vacuum source, afluid source, and a power signal source, the delivery device having ahousing portion containing (1) an ultrasonic transducer securedcoaxially about a mounting post within the housing portion and (2) a tipportion having a sleeve and a cannula, the cannula being coupled to theultrasonic transducer and received in the sleeve to define a coveredportion and an exposed portion; generating ultrasonic energy by sendinga power signal from the power signal source to the ultrasonictransducer; transmitting the ultrasonic energy from the ultrasonictransducer to the cannula, such that the exposed portion of the cannuladelivers ultrasonic energy at a frequency that is pre-selected from 25kHz to 29 kHz to debride musculoskeletal tissue upon percutaneousinsertion of the tip portion; percutaneously inserting the tip portionproximal to a musculoskeletal tissue site; and delivering fluid to themusculoskeletal tissue site through the tip portion; aspirating from themusculoskeletal tissue site through the tip portion; and debridingmusculoskeletal tissue with the tip portion debriding musculoskeletaltissue with the ultrasonic energy delivered from the cannula whileultrasonically imaging the tip portion of the delivery device.
 2. Themethod of claim 1, where connecting the delivery device to the vacuumsource, the fluid source and the power signal source includes remotelyconnecting the delivery device to a controller having the vacuum source,fluid source, and the power signal source, the controller including aremovable tubing cassette remotely connected to the delivery device, themethod further comprising: replacing the removable tubing cassette witha second tubing cassette; providing a second delivery device comprisinga second ultrasonic transducer, a second cannula, and a second exposedportion; remotely connecting the second tubing cassette to the seconddelivery device; generating ultrasonic energy by sending a power signalfrom the controller to the second ultrasonic transducer of the seconddelivery device; and transmitting the ultrasonic energy from the secondultrasonic transducer to the second cannula of the second deliverydevice, such that the second exposed portion of the second cannuladelivers ultrasonic energy.
 3. The method of claim 1, further comprisingproviding a connector portion and an insertion portion on, wherein theportion and an insertion portion having an effective outer diameter thatis less than the connector portion and the effective outer diameter ofthe insertion portion having a value of 12 gauge to 25 gauge.
 4. Themethod of claim 3, wherein the effective outer diameter of the insertionportion has a value of 20 gauge to 25 gauge.
 5. The method of claim 1,further comprising providing a connector portion and an insertionportion on the sleeve, the insertion portion having a lateral width of0.4 mm to 2.5 mm.
 6. The method of claim 5, wherein the lateral width ofthe insertion portion is 0.5 mm to 2.1 mm.